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Motivational Interview and Orthodontic Patients

29 de abril de 2021 actualizado por: Universidad Iberoamericana

The Effect of Motivational Interviewing on Oral Hygiene Behavior in Patients With Fixed Orthodontic Appliances: A Randomised Clinical Trial

A parallel-group randomized clinical trial was conducted with 45 patients of the Orthodontic Clinic of Universidad Iberoamericana's (UNIBE) Postgraduate Unit. The study hypothesis was that motivational interview plus oral hygiene instructions would be more effective in maintaining long-term oral hygiene in comparison with conventional oral hygiene instructions alone.

A computer-generated list of numbers created with Statistical Package for the Social Sciences (SPSS) V21.0 was used to random allocate participants into the experimental or the control group. Monthly oral hygiene instructions and a G.U.M. kit were given to the sample. Additionally, the experimental group received motivational interviewing sessions by a trained periodontist. Simplified Oral Hygiene Index, Gingival Index, Periodontal Probing Depth and Bleeding on Probing were recorded at baseline, three and six months after the beginning of the study. Repeated-measures analysis of variance and chi-squared test were conducted.

Descripción general del estudio

Descripción detallada

Sample calculation A power analysis was carried out to determine the number of subjects needed to achieve a Simplified Oral Hygiene Index (SOHI) significant interaction with the study groups when applying repeated measures ANOVA. The total number of completed subjects needed to achieve power of 0.90 with an alpha (α) of 0.05, an effect size (f) of at least .25 was determined to be 36; taking into consideration a possible 10% attrition rate, 45 subjects were recruited, consented and randomized to either the experimental or control group.

Due to the matter that repeated measures ANOVA treats each measurement as a separate variable, and it's preferable to use listwise deletion, if one measurement is missing, the whole case gets dropped. For this reason and therefore the incontrovertible fact that the trial suffers attrition, the sample for the three measurements was reduced to 32 subjects.

Randomization A simple randomization procedure was executed by the principal investigator to allocate the participants into one of the study groups. A computer-generated list of numbers was created using the software SPSS V21.0, with a 1:1.25 allocation ratio.

Two dentists enrolled and allocated the participants according to the order of arrival and following the list of random numbers. A coding system was used as a concealment mechanism, which consisted of colored labels attached to the participants' file. Thus, the participant and the evaluator (the periodontist who recorded the data) were masked.

Study intervention An interviewer was in charge of providing oral hygiene instructions for both groups. All the participants received a G.U.M. kit with special orthodontic hygiene tools. Then, the patients of the experimental group received a motivational interviewing session.

Afterward, the clinical parameters were measured by another periodontist. Monthly follow-up appointments were scheduled for the orthodontic check-ups to deliver a new G.U.M. kit, to reinforce the OHI and MI, and to register the periodontal parameters. The important data for this research was the one recorded at baseline, three and six months after the intervention.

Statistical analysis Mean Simplify oral hygiene index (SOHI), gingival index (GI), periodontal probing depth (PPD), and bleeding on probing (BoP) scores were compared between groups across three-time points using repeated-measures mixed-model analysis of variance. Tests for equality of variances and sphericity to check for homoscedasticity were performed due to the problem of sample attrition. Nevertheless, it was not found any violation to these assumptions in any of the variables included in the analysis. SPSS software was used for all calculations (IBM SPSS 25th version). Due to the nominal level of measurement of the variable BoP, it was performed a chi-squared test for each three time points to check if there were any differences between the two experimental conditions.

Tipo de estudio

Intervencionista

Inscripción (Actual)

45

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Distrito Nacional
      • Santo Domingo, Distrito Nacional, República Dominicana, 22333
        • Universidad Iberoamericana UNIBE

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 40 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patients with 18-40 years old, systemically healthy, without active dental caries lesions or periodontal diseases, who were candidates for fixed orthodontic appliances.

Exclusion Criteria:

  • Smokers and pregnant patients.
  • Participants were discarded if they decided voluntarily to abandon the study of the orthodontic treatment or if they didn't attend to the periodical check-ups.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Experimental group
A trained periodontist delivered oral hygiene instructions and motivational interviewing sessions. All the participants received a G.U.M. kit with special orthodontic hygiene tools.
A periodontist was trained and evaluated by two expert psychologists in MI, who also supervised the interviewer to ensure that the intervention was properly applied. The periodontist conducted sessions of motivational interviewing monthly to the participants of the experimental group.
Otros nombres:
  • Entrevista motivacional
A periodontist delivered OHI to all the participants of both studied groups. Also, every single patient received a G.U.M. kit with special orthodontic hygiene tools.
Otros nombres:
  • OHI
Comparador activo: Control group
A trained periodontist delivered only oral hygiene instructions. All the participants received a G.U.M. kit with special orthodontic hygiene tools.
A periodontist delivered OHI to all the participants of both studied groups. Also, every single patient received a G.U.M. kit with special orthodontic hygiene tools.
Otros nombres:
  • OHI

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Simplified Oral Hygiene Index
Periodo de tiempo: Base line.
six surfaces (from fou r posterior and two anterior teeth ) are examined for debris and calculus, whereas 12 surfaces are examined.
Base line.
Simplified Oral Hygiene Index
Periodo de tiempo: 3rd month
six surfaces (from fou r posterior and two anterior teeth ) are examined for debris and calculus, whereas 12 surfaces are examined.
3rd month
Simplified Oral Hygiene Index
Periodo de tiempo: 6th month
six surfaces (from fou r posterior and two anterior teeth ) are examined for debris and calculus, whereas 12 surfaces are examined.
6th month

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Gingival Index
Periodo de tiempo: Base line, 3 and 6 months after the intervention.
Each of the four gingival areas of the tooth is given a score from 0 to 3; this is the gingival índex for the area.
Base line, 3 and 6 months after the intervention.
Periodontal Probing Depth
Periodo de tiempo: Base line, 3 and 6 months after the intervention.
One tooth per sextant was chosen and the average was calculated.
Base line, 3 and 6 months after the intervention.
Bleeding on Probing
Periodo de tiempo: Base line, 3 and 6 months after the intervention.
Dichotomic response after probing the gingival sulcus.
Base line, 3 and 6 months after the intervention.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Colaboradores

Investigadores

  • Investigador principal: Henry A Adames, MsC, Universidad Iberoamericana

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

16 de junio de 2017

Finalización primaria (Actual)

12 de noviembre de 2018

Finalización del estudio (Actual)

12 de noviembre de 2018

Fechas de registro del estudio

Enviado por primera vez

23 de abril de 2021

Primero enviado que cumplió con los criterios de control de calidad

29 de abril de 2021

Publicado por primera vez (Actual)

4 de mayo de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de mayo de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

29 de abril de 2021

Última verificación

1 de abril de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • CEI2017-06

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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